Kornimate/medical-research-clean huggingface dataset:
trial of ultrahypofractionated focal salvage radiotherapy for isolated prostate bed recurrence after radical prostatectomy

Conditions: Recurrent Prostate Cancer

Summary: the main objective of the trial is to explore the efficacy and safety of combining short-term androgen deprivation therapy (adt) over 6 months to focal ultrahypofractionated salvage radiotherapy (srt) delivered in 5 fractions to the site of local recurrence within the prostate bed after radical prostatectomy where multiparametric magnetic resonance imaging (mpmri) and prostate-specific membrane antigen (psma) pet/ct are used to precisely identify the local recurrence and compare it to previously published literature.


Eligibility criteria:
inclusion criteria: 1. written informed consent according to ich/gcp (international council for harmonisation/good clinical practice) regulations before registration and prior to any trial specific procedures 2. age ≥ 18 years at time of registration 3. who performance status 0-1 4. lymph node negative adenocarcinoma of the prostate treated with radical prostatectomy (rp) at least 6 months before trial.tumor stage pt2a-3b, r0-1, pn0 or cn0. according to the union for international cancer control (uicc) tnm 2009. 5. evidence of measurable local recurrence at the prostate bed detected by psma pet/ct and mpmri within the last 3 months. in case of unclear local recurrence, a biopsy confirmation is recommended. 6. patient must have non-metastatic (n0, m0) disease, as defined by a lack of nodal or distant metastases seen on psma pet/ct scan 7. patients must have non-castrate levels of serum testosterone (≥50 ng/dl). 8. patients must not have previously received hormonal therapy (lhrh agonists, antiandrogen, or both, or bilateral orchiectomy). 9. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial exclusion criteria: 1. persistent psa (\> 0.4 ng/ml) 4 to 20 weeks after rp 2. previous hematologic or primary solid malignancy within 3 years prior registration with the exception of curatively treated localized non-melanoma skin cancer 3. usage of products known to affect psa levels within 4 weeks prior to start of trial treatment phase including any form of androgen suppression agents and androgen deprivation therapy 4. bilateral hip prosthesis 5. severe or active co-morbidity likely to impact on the advisability of srt 6. treatment with any experimental drug or participation within a clinical trial within 30 days prior to registration (exception: concurrent participation in the biobank studies is allowed)

Keywords: prostate salvage radiation local recurrence stereotactic radiotherapy hypofractionation
effects of sulawesi propolis extract on lesion growth, apoptotic and inflammatory activity of the rat endometriosis tissue

Conditions: Endometriosis; Peritoneum; Endometriosis

Summary: this study aims to evaluating inflammatory and apoptotic activity in rat's endometriosis lesion treated by propolis compared to dienogest

propolis has known of having various efficacy. the main benefits are as antimicrobial, antioxidant, anti-inflammatory, immunomodulatory and antiapoptotic.propolis has even been shown to have an antibacterial effect in vitro, without requiring human immunological reactions. the immunological effect of propolis is generated through immune suppression directly and decreasing cytokine production which stimulates immune process. although proven to have a various efficacy, propolis can't be used as a therapeutic drug due to the difficulty of obtaining standard chemical composition as a requirement to be the drug's substances. therefore, it is necessary to have biological composition in each propolis prepartions written down before comparing the efficacy. anti tumor activity by propolis, which has been tested in animal previously, showed that propolis can inhibit dna synthesis in tumor cells, induce cell apoptosis and activate macrophage to produce factors which regulate the function of b, t, as well as nk cell. dienogest, is the next choice of progestin drug class. it has high selectivity binding in progesterone receptors, inhibits cytokine secretion in endometriosis stroma cell and induces apoptosis in endometriosis cell. dienogest also has slight inhibitory effect against estradiol, so it can deminisce the symptoms due to hypoestrogenic such as decresing in bone mass density.

Eligibility criteria:
inclusion criteria: * female ratus rat type * having normal estrus cycle exclusion criteria: * nothing

Keywords: endometriosis propolis
dynamic contrast enhanced mri (dce-mri) diffusion weighted mri (dw-mri) and magnetic resonance spectroscopy (mrs) of head and neck tumors

Conditions: Head and Neck Cancer

Summary: magnetic resonance imaging (mri) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. dynamic contrast enhanced-magnetic resonance imaging (dce-mri) uses faster imaging and contrast material (a substance used to make specific organs, blood vessels, or tumors easier to see) that is given by vein. diffusion weighted magnetic resonance imaging (dw-mri) allows to measure the motion of water around the cells in the tumor. proton magnetic resonance spectroscopy (mrs) obtains chemical information from the tumor. during mrs, signals are detected from the chemicals (spectroscopy) naturally present in your tumor using radio waves. dce-mri, dw-mri and mrs give extra information which is not available with the regular mri. the regular mri only shows pictures of the tumor while the dce-mri also gives information about the blood vessels of the tumor. dw-mri provides information related to the state of the tumor tissue with regards to the quality or condition of cells present in it and mrs gives information about the chemical makeup of the tumor. the purpose of this study is to see whether dce-mri, dw-mri and mrs done before treatment can predict which patients will do well with either surgery or chemo-radiation therapy. this study will also see if dce-mri, dw-mri and mrs done early in treatment can tell if the therapy is working.


Eligibility criteria:
inclusion criteria: * patients with histologically proven diagnosis of head and neck cancer or patients with tumors strongly suspicious for head and neck cancer due to clinical features or fna (fine needle aspiration) cytology assessment. * will undergo surgery or chemo-radiation treatment * patients must be 18 years or older and have the ability to give informed consent exclusion criteria: * claustrophobia * known reaction to gd-dtpa * pre-operative radiation to primary tumor site * contraindication to mri 1. pacemaker 2. aneurysmal clips 3. metal implants in field of view 4. pregnant or nursing women 5. age and mental status wherein he/she is unable to cooperate for mri study

Keywords: head and neck cancer head cancer neck cancer dynamic contrast enhanced mri magnetic resonance spectroscopy (mrs) diffusion weighted mri (dw-mri) 06-007
preoperative oral carbohydrate for nausea and vomiting prevention during cesarian section

Conditions: Postoperative Nausea and Vomiting

Summary: post-operative nausea and vomiting (ponv) in women undergoing subarachnoid anesthesia for caesarean section is an important clinical problem. the aim of this study is to compare the effectiveness of oral carbohydrate loading to standard pre-operative fasting in patients undergoing elective cesarean section on the incidence and severity of ponv and biochemical parameters indicating ketosis.

post-operative nausea and vomiting (ponv) in women undergoing subarachnoid anesthesia for caesarean section is an important clinical problem. known mechanisms underlying ponv are based on prolonged fasting, hypotension due to concomitant sympatholysis during anesthesia, bradycardia due to increased vagal tone, visceral stimulation during surgery and intrathecal administered opioids. however, the identification of patients exposed to this problem and appropriate perioperative preparation is of key importance. an analysis of risk factors for postoperative nausea and vomiting in patients undergoing elective cesarean section under spinal anesthesia is of major clinical importance. the aim of this study is a comparison of the effectiveness of oral carbohydrate loading strategy as compared with standard pre-operative fasting in patients undergoing elective cesarean section under spinal anesthesia on the incidence and severity of ponv and biochemical parameters indicating ketosis.

Eligibility criteria:
inclusion criteria: 1. age \>=18 years. 2. scheduled for an elective cesarean section. 3. uncomplicated pregnancy. 4. planned for spinal anesthesia. 5. asa i or asa ii. exclusion criteria: 1. history of diabetes. 2. history of gastro-intestinal reflux (gerd). 3. unable or unwilling to sign an informed consent. 4. contraindications to spinal anesthesia. 5. contraindication to oral carbohydrate formula.

Keywords: nausea vomiting oral carbohydrate fasting
i-stitch for bilateral sacrospinous ligament fixation (sslf)

Conditions: Pelvic Organ Prolapse; Genital Prolapse

Summary: the purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-stitch device for bilateral sacrospinous ligament fixation (sslf) in pelvic organ prolapse (pop) repair.

the i-stitch instrument is a reusable instrument for attaching sutures to tissue with or without surgical mesh implants in urogynaecology. it is used together with the i-stitch loading units. the use of i-stitch for the fixation of surgical urogynaecological mesh implants (e.g. bsc mesh, ingynious) has already been proven in several studies. the aim of the present retrospective study is to generate clinical data to show the safety and performance of the i-stitch instrument in bilateral sacrospinous ligament fixation (sslf) without the use of a surgical mesh.

Eligibility criteria:
inclusion criteria: * surgery for pop * sslf with usage of i-stitch device (\& i-stitch loading units) * concomitant procedures are allowed * women minimum 18 years old * written informed consent for surgery exclusion criteria: * infection (active or latent) * allergies to the materials used * benign or malignant changes * anticoagulation disorders * autoimmune connective tissue disorders * any uterus pathologies

Keywords: bilateral sacrospinous ligament fixation suture attachment medical device
subthalamic steering for therapy optimization in parkinson's disease

Conditions: Parkinson Disease

Summary: twenty patients with idiopathic parkinson's disease (pd) will be included into this single center randomized controlled double-blind clinical trial (rct) in a cross-over design. the treatment consists of two different stimulation settings using (i) conventional omnidirectional stimulation of the subthalamic nucleus \[stn_o\] as active comparator and (ii) directional steering of stn stimulation via a segmented electrode contact \[stn_d\].

twenty pd patients will be enrolled in this cross-over double-blind rct to evaluate both the safety and efficacy of directional stn stimulation \[stn_d\] compared with standard omnidirectional stn stimulation \[stn_o\]. the primary outcome measure is objectively quantified muscle rigidity of the upper extremity, i.e., surface emg recordings of the biceps and triceps muscle during standardized extension/flexion of the elbow joint (levin et al., 2009) assessed 6 months after implantation in cross-over design. the trial is designed to detect with an 80% power a change of 0.27 ma of the therapeutic stimulation threshold with two-tailed p \< 0.05 (wilcoxon rank sum test). secondary outcome measures address clinical motor, non-motor, neurocognitive and neuropsychiatric symptoms, freezing of gait, and quality of life. visits are scheduled at weeks 1 (v1), 6 (v2), 24 (v3), 27 (v4), and 30 (v5) from baseline (v0).

Eligibility criteria:
inclusion criteria: * written informed consent * idiopathic parkinson's disease (according to the "british brain bank criteria" (hughes, 1992) including genetic forms exclusion criteria: * cognitive impairment (mini mental state exam \< 20) * suicidality, psychosis * other severe pathological chronic condition that might confound treatment effects or interpretation of the data * pregnancy

Keywords: stn dbs steering segmented electrode leads
soft tissue volume gain and stability comparing palate and tuberosity

Conditions: Tooth Loss; Recession, Gingival

Summary: the goal of this study is to compare clinical and histologically the soft tissue changes in terms of volume gain and stability around dental implants in cases where a subepithelial connective tissue graft from the palate or from the tuberosity is used randomly

understanding the importance of the soft tissue around implants have lead clinicians to develop surgical approaches to augment it. the majority of them, are described as bilaminar techniques obtaining a subephitelial connective tissue graft (sctg) from the palate (p). however, recent studies have demonstrated that tuberosity (t) tissue is a very dense and coarse tissue that seems to contain more collagen and less fat and glandular tissue than that from the p, and therefore may have better tissue qualities for soft tissue augmentation, but there is limited scientific evidence comparing these areas. the main goal of this study is to compare the soft tissue volume gain and stability around implants in cases where a sctg of the same dimensions from the p or t is used randomly. to calculate volume changes and stability an intraoral optical scan is used and three-dimensional images superimposed. the secondary goal is to compare histologically both tissues and changes in clinical parameters. histomorphometry and immunohistochemistry evaluating levels of type i-iii collagen, long lysyl hydroxylase, matrix metalloproteinase 1-2, and monoclonal antibody against cytokeratin 4-10-13 is performed.

Eligibility criteria:
inclusion criteria: * patient must be ≥18 years and able to understand the nature of the proposed surgery and to a signed informed consent. * implant must be located between 2 fixed reference points i.e. clinical crowns. * all implants locations with a need of a soft tissue volume augmentation. * palate must have ≥2mm of thickness at premolar area. * tuberosity \> 12mm in length. * full mouth plaque and bleeding score \<20%. exclusion criteria: * previous soft tissue augmentation in the area. * heavy smokers (\> 10 cigarettes per day). * local or systemic conditions that would interfere with routine periodontal therapy (non controlled diabetes, liver function disorder, immunosuppressant disease, autoimmune disease). * allergy to non-steroidal anti-inflammatory drugs. * patients taking medications that cause gingival enlargement * gingival idiopatic overgrowth

Keywords: volume gain soft tissue augmentation dental implants histology
functional knee phenotypes of patients operated on for total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: the aim of this study was to analyze the coronal alignment of a large population of patients undergoing total knee arthroplasty using a modern classification of the knee phenotypes found in a population of non-osteoarthritic patients.

methods five hundred and four navigated total knee arthroplasties will be analyzed. the following angles will be measured with a computer image free navigation system: medial femorotibial mechanical angle without stress and with maximum manual stress to reduce deformation, and medial distal femoral mechanical angle. the native medial distal femoral and medial proximal tibial angles will be calculated. the data will be analyzed as numerical and categorical data. these data will be then compared with those published in a non-arthritic population, considered as a control group. the main criterion will be the percentage of subjects with normal overall coronal alignment, defined by the association of a normal native medial distal femoral angle and a normal native medial proximal tibial angle. the secondary criteria will be the percentages of subjects with normal medial femorotibial mechanical angle, normal native medial distal femoral angle and normal native medial proximal tibial angle. the influence of gender on primary and secondary criteria in the study group will be analyzed. the most frequent phenotypes in the study group will be identified.

Eligibility criteria:
inclusion criteria: * patient aged ≥ 18 years * patient operated between 01/01/2011 to 02/28/2021 by two experienced surgeons of a total knee prosthesis using a navigation system without image (orthopilot ®, aesculap, tuttlingen, frg) allowing to measure during the intervention the anatomical parameters of the subject before implantation; * records including a complete intraoperative anatomical analysis; * subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research. exclusion criteria: * subject who expressed their opposition to participating in the study * impossibility of giving the subject informed information (difficulties in understanding the subject, etc.) * incomplete or absent anatomical analysis * subject under guardianship, curatorship or safeguard of justice

Keywords: knee osteoarthritis knee osteoarthritis knee arthroplasty total knee arthroplasty navigated implantation
multicentre study to determine the cardiotoxicity of r-chop compared to r-comp in patients with diffuse large b-cell lymphoma

Conditions: Diffuse Large B-Cell Lymphoma

Summary: diffuse large b-cell lymphoma is the most prevalent subgroup within malignant lymphoma. clinical benefit has been shown for the treatment with cyclophosphamide, doxorubicin, vincristin and prednisolone (chop regimen); this could be further improved recently by the addition of rituximab (r-chop), a monoclonal antibody. improved response and overall survival rates make it necessary to evaluate late toxicities of the therapy regimens. cardiotoxicity is a known risk factor of specific chemotherapies, with 7% patients being affected if doxorubicin cumulative doses are under 550mg/sqm. retrospective data analyses indicate that this incidence of cardiotoxicity may be higher under combination chemotherapy. liposomal doxorubicin has been shown to have lower cardiotoxic effects and at the same time equivalent or higher efficacy compared to conventional doxorubicin. the aim of this study is to evaluate alternative regimens for the treatment of diffuse large b-cell lymphoma, substituting liposomal doxorubicin (r-comp) for conventional doxorubicin (r-chop).


Eligibility criteria:
inclusion criteria: * histologically confirmed, cd20 positive, diffuse large b-cell lymphoma (dlcl) * measurable disease according to international criteria * male or female * age 18 years and above * written informed consent exclusion criteria: * myocardial infarction within 6 months prior to study entry * cardiac insufficiency nyha grade 3 or 4 * previous treatment with chemotherapy or radiotherapy * cns involvement of the disease * positive for hiv * who performance index 3 or 4 * secondary malignoma * concurrent disease that prohibits chemotherapy * known hypersensitivity towards the study interventions or their constituents * neutropenia or thrombopenia
nociception index level (nol) perioperative monitoring during regional anesthesia

Conditions: Regional Anesthesia; Pain; Intraoperative Monitoring

Summary: this prospective observational study was conducted to assess pain using nol index under locoregional anesthesia for orthopedic surgery of the upper limb. we included 50 consecutive adult patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia. the locoregional anesthesia was performed under ultrasound, with or without neurostimulation. intraoperative pain is assessed using nol index monitoring, algiscore and numerical scale, and second point study is the midazolam and propofol requirement.

introduction: intraoperative pain assessment is difficult and based on indirect parameters of sympathetic-parasympathetic system stimulation. recently, the nociception level index (nol™) providing a value from combination of multiple physiological parameters to measure pain has been developed to enable intraoperative pain monitoring during general anesthesia. while this monitoring has also been used postoperatively in awake patients, data are scarce to assess pain under locoregional anesthesia. this study was conducted to assess pain using nol index under locoregional anesthesia for orthopedic surgery of the upper limb. method: 50 consecutive patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia were included. exclusion criteria were emergencies, request for general anesthesia, and patients under 18 years of age. all patients were informed and consented to the technique of locoregional anesthesia and pain monitoring without change of practice. after premedication with oral hydroxyzine, locoregional anesthesia was performed under ultrasound, with or without neurostimulation. monitoring began as soon as the venous infusion was started, and parameters were recorded at the time of locoregional anesthesia, tourniquet inflation, surgical incision, skin closure and dressing. pain is also assessed using the algiscore by the nurse and the numerical scale (0 to 5) and satisfaction score at the end of the procedure. the need to administer midazolam or propofol at the anesthetist's discretion is noted, as is the effectiveness of locoregional anesthesia (conversion to general anesthesia). data were analyzed using friedman and mann-whitney tests.

Eligibility criteria:
inclusion criteria: scheduled upper limb orthopedic surgery under regional anesthesia exclusion criteria: patient less than 18 years old emergency surgery patient refusal of regional anesthesia chronic neurocognitive disease

Keywords: nociception regional anesthesia intraoperative monitoring nol monitor
safety and efficacy predimenol for headache

Conditions: Headache

Summary: this is a prospective, double-blind, placebo-controlled and randomized study aimed to obtain a description of the efficacy and safety of predimenol in alleviating headache.

predimenol is a bioactive fraction extracted from phaleria macrocarpa pericarpium (mahkota dewa). there will be 20 subjects per group (a total of 60 subjects) planned to be enrolled in the study. the investigational drug: tablet @200 mg of predimenol. dose administration: one singe dose (two tablets) of predimenol or placebo.

Eligibility criteria:
inclusion criteria: 1. healthy men or women aged 18 to 60 years with acute moderate tomoderate-severe headache. 2. signing the informed consent. exclusion criteria: 1. body temperature of \>37.3˚c and/or refuse to follow health protocol for covid-19. 2. known hypersensitivity to herbal drugs. 3. pregnant or lactating women. 4. have received any analgesic or anti-inflammatory drugs within the past 12 hours. 5. presence of vomiting or diarrhea within the past 24 hours or still ongoing at the start of study. 6. severe illness, e.g. severe hypertension, or any known organic diseases that may cause headache.

Keywords: predimenol headache
quality of life of taiwan people living with hiv

Conditions: HIV-1-infection

Summary: to survey qol and relevant factors in plwh


Eligibility criteria:
inclusion criteria: * adult patient living with hiv, aged \>= 18 years old exclusion criteria: * known cognitive dysfunction or attention deficient to complete the survey